BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSUTURE SURGINEEDLE (VERESS NEEDLE)

    MDR report key: 84678 · Received July 1, 1996

    Report

    Report Number
    84678
    Event Type
    Injury
    Date Received
    July 1, 1996
    Date of Event
    April 9, 1996
    Report Date
    April 19, 1996
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    FHP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRE-OP DX-ACUTE APPENDICITIS, RULE OUT PERFORATION. ON 4/9/96, ATTEMPTED DIAGNOSTIC LAPAROSCOPY. WHILE DOING SO, INTRAGENIC ACCIDENTAL INJECTION OF CO2 INTO THE LIVER CAUSING A VENOUS EMBOLI, CREATING CARDIAC FLUTTER-VENTRICULAR TACHYCARDIA WITH HYPOTENSION, REQUIRING A CARDIAC RESUSITATION AND ALSO 200 JOULE CARDIAC DEFIBRILLATION INTRAOP. ALSO DID OPEN APPENDECTOMY, EXPLORATORY LAPAROTOMY, PLACEMENT OF A DRAIN. RIGHT FEMORAL ARTERIAL EXPLORATION WITH REPAIR OF THE TWO CATHETER-RELATED PERFORATION OF THE FEMORAL ARTERY. PLACEMENT OF THE RIGHT FEMORAL ARTERIAL LINE WITH NO COMPLICATIONS INITIALLY. PT ALSO RECEIVED BLOOD. HAS DEVELOPED THROMBUS OF RIGHT COMMON FEMORAL ARTERY (NOTED IN PROGRESS NOTES). HAS BEEN ON HEPARIN AND MAY BE HAVING SURGERY IN FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE SURGINEEDLE (VERESS NEEDLE) Implant DISPOSABLE PNEUMOPERITONEUM NEEDLE FHP UNITED STATES SURGICAL CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening| R MODEL#2054.00 SER. -099 INPUT 120V, 1 AMP 60HZ| RICHARD WOLF ELECTRONIC CO2 INSUFFLATOR